Circumference Reduction
Conditions
Keywords
body contouring, body shaping, circumference reduction
Brief summary
The purpose of this study is to determine whether low level laser light therapy is effective in reducing circumference of the waist, hips, thighs and upper abdomen over a 6 week period.
Detailed description
The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010. While surgical cosmetic procedures significantly increased from 2010 to 2011, the overall growth in cosmetic procedures is primarily driven by a substantial rise in minimally-invasive procedures, that increased 6%, with nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011. This highlights the growing consumer demand for non- or minimally-invasive cosmetic procedures that do not involve surgical procedures such as liposuction and the associated risks, potential complications and lengthy and painful recovery processes. Low level laser light therapy offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving body circumference reduction. Justification for the assertion of anticipated safety and effectiveness of application of the Erchonia® EZ6 Laser low level laser therapy for the reduction of body circumference is found through three Food and Drug Administration (FDA) clearances for Erchonia® Low Level Laser devices for body circumference reduction indications, as follows: K123237 (532 nanometer (nm) green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs. K121695 & K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) & Erchonia® Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs. K121690 & K120257 (635 nm red light diodes): Erchonia® MLS, Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms. Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for application for body circumference reduction indications for multiple body areas. The intended application/indication of the EZ6 in this study is comparable to the above FDA-cleared indications, with the study intent being to evaluate the comparative efficacy of a six week, once weekly 60 minute treatment administration protocol employing 6 red light diodes to the established efficacy of the current two week, thrice weekly 40 minute treatment administration protocol with application of five red light diodes on reduction of hips, waist, thighs and upper abdomen circumference.
Interventions
DEVICEErchonia EZ6 Laser
The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) between 25 kg/m² and 40 kg/m² * Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues that do not respond to diet and exercise for the hips, waist, thighs and upper abdomen. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery developed by A joint Ad Hoc Committee of the American Society of Lipo-Suction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS)) * Willing and able to abstain from treatments other than the study procedure for body contouring/circumference reduction/weight loss during study participation * Willing and able to maintain typical diet and exercise regimen during study participation
Exclusion criteria
* Body Mass Index (BMI) less than 25 kg/m² or greater than 40 kg/m² * Known cardiovascular disease * Cardiac surgeries such as bypass, heart transplant surgery, pacemakers * Prior surgical intervention for body sculpting/weight loss * Medical, physical, or other contraindications for body sculpting/weight loss * Current use of medication known to affect weight levels/cause bloating or swelling and for which abstinence during study participation is not possible * Any medical condition known to affect weight levels and/or cause bloating or swelling. * Diagnosis of, and/or taking medication for, irritable bowel syndrome. * Active infection, wound or other external trauma to the study treatment areas * Known photosensitivity disorder * Active cancer or currently receiving treatment for cancer * Pregnant or planning pregnancy prior to study participation end * Serious mental health illness such as dementia/schizophrenia; psychiatric hospitalization in past two years. * Developmental disability or cognitive impairment that may preclude adequate comprehension of the consent form and/or ability to record the study measures * Involvement in litigation/worker's compensation/disability benefits related to the study parameters * Participation in clinical research in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Combined Circumference Measurements | Baseline and 6 weeks | Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline and 6 weeks | Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period. |
| Change in Body Mass Index (BMI) | Baseline and 6 weeks | Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success. |
| Subject Satisfaction With Study Outcome Rating | 6 weeks | At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?, using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erchonia EZ6 Laser The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.
Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Erchonia EZ6 Laser |
|---|---|
| Age, Continuous | 46.39 years STANDARD_DEVIATION 9.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 54 participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Change in Combined Circumference Measurements
Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia EZ6 Laser | Change in Combined Circumference Measurements | -5.36 inches | Standard Deviation 1.85 |
p-value: <0.0001t-test, 2 sided
Secondary
Change in Body Mass Index (BMI)
Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia EZ6 Laser | Change in Body Mass Index (BMI) | -0.28 kg/m2 | Standard Deviation 0.11 |
p-value: <0.005t-test, 2 sided
Secondary
Change in Body Weight
Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia EZ6 Laser | Change in Body Weight | -1.40 pounds | Standard Deviation 0.85 |
p-value: <0.05t-test, 2 sided
Secondary
Subject Satisfaction With Study Outcome Rating
At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?, using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erchonia EZ6 Laser | Subject Satisfaction With Study Outcome Rating | Very Satisfied | 28 participants |
| Erchonia EZ6 Laser | Subject Satisfaction With Study Outcome Rating | Somewhat Satisfied | 14 participants |
| Erchonia EZ6 Laser | Subject Satisfaction With Study Outcome Rating | Neither Satisfied Nor Dissatisfied | 4 participants |
| Erchonia EZ6 Laser | Subject Satisfaction With Study Outcome Rating | Not Very Satisfied | 3 participants |
| Erchonia EZ6 Laser | Subject Satisfaction With Study Outcome Rating | Not At All Satisfied | 3 participants |